A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Single-Dose, Randomized, Open-Label, Parallel Group Study to Assess the Relative Bioavailability and Tolerability of Two Formulations of Crenezumab in Healthy Subjects Following Subcutaneous Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427243
• Other study ID #: GP29172
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2015
• Last updated: November 1, 2016
• Start date: April 2015
• Est. completion date: July 2015

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male or female 18 to 65 years of age at Screening, inclusive

• Body mass index (BMI) 18.5 to 32 kg/m^2, inclusive

• Body weight 50 to 100 kg, inclusive

• Females must be of non-childbearing potential

• Males of reproductive potential must agree to remain abstinent or must be using highly effective contraception and must avoid sperm donation, from Screening until at least 8 weeks after the last study drug administration or until study completion, whichever is later

Exclusion Criteria:

• Significant medical history, psychiatric disorder, or acute infection at Screening (as determined by Investigator)

• History of alcoholism or drug addiction within 6 months prior to CRU Check-in

• Use of tobacco or nicotine-containing products from 6 months prior to CRU Check-in and during the study

• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred wtihin 30 days or 5 half-lives, whichever is longer, prior to CRU Check-in

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Crenezumab

• Crenezumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2)		Day 1 through Day 85 or early termination	No
Secondary	Incidence, nature, and severity of adverse events		Consent through Day 85 or early termination	No
Secondary	Incidence of anti-therapeutic antibodies (ATAs) to crenezumab		From Day 1 (Predose) through Day 85 or early termination	No